Regulatory Affairs Labeling Operations Specialist

Duration:
1 year (possibility to extend)
Schedule:
FlexibleJob Description:
We are seeking a dynamic and experienced Regulatory Affairs Labeling Operations Specialist to process critical tasks related to final printed pharmaceutical labeling for launch and lifecycle management projects, guided by company content of labeling, FDA Patient Labeling Resources, FDA Label Negotiations, and industry trends.
This role requires labeling verification, including reviews across the product family of leaflets, carton and container labels, as well as device labels. The ideal candidate will collaborate with cross-functional teams, including Regulatory Affairs Therapeutic Area (TA) Managers, Global HQ, Labeling Projects and Planning Coordinators (LPPC), Graphic Designers, Marketing, and Supply Chain.Responsibilities:
Top 3 Must-Haves:

1. Vast experience in PLR - SRPI - CFR format requirements for branded PI, MG, PPI, IFU, and container labeling.
2. Highly proficient in proofreading prescription pharmaceutical labeling using TVT for text comparison and verification (not OTC).
3. Ability to rapidly reassess and realign priorities when circumstances change, taking decisive action to keep work moving forward efficiently.

• Review and provide regulatory guidance on commercial labeling materials to ensure compliance with CFR and FDA labeling requirements.
• Identify labeling issues, troubleshoot, and communicate effectively with relevant stakeholders to ensure timely resolution.
• Monitor, evaluate, and recommend improvements to labeling processes, quality, and system tools in alignment with FDA regulations and industry best practices.

Essential Functions:
Label Development:

• Assist in the Final Printed Labeling review and approval process based on final approved labeling content from the FDA.
• Collaborate with TA, LPPC, and Graphic Designers to ensure successful, on-time launch of product labeling per company launch readiness timelines.
• Ensure additional filing requirements are completed for approved labeling content, including SPL Drug Listing, FDA 2253s, and Puerto Rico registrations.

Labeling Tools:

• Serve as an experienced user of all labeling tools, with emphasis on SPL ALiCE A4L environment and high proficiency in TVT usage.
• Other systems include Vault RIM (Veeva), Esko (LIFT Artwork Management), Adobe Acrobat, etc., along with coordinating technical support needs with internal IT groups.
• Utilize FDA portals and tools, including ESG NexGen, FURLS, SPL Help Desk, FDALabel, Drugs@FDA, and coordinate with internal groups and external agencies to resolve issues.

Regulatory Support:

• Participate in cross-functional teams locally and globally, demonstrating good judgment in troubleshooting and resolving problems of moderate scope and complexity.
• Demonstrate competence in:
  • Lot Distribution Data Reports
  • CARES Act Distribution Reporting
  • SPL Blanket No Change Certification
  • FDA Establishment Registrations
  • FDA Annual Reports
  • FDA PBRER
  • Certificate of Pharmaceutical Products
  • PRDOH Puerto Rico Registrations

Experience:

• Bachelor’s degree preferred, with a minimum of 3 years of progressively responsible experience in a pharmaceutical, biotechnology, or related environment, OR an equivalent combination of education and experience with a focus on labeling development and maintenance.
• 3-5 years of proven experience supporting processes on branded products (not generics).
• Proficiency with:
  • 21 CFR Labeling
  • Physician Labeling Rule (PLR)
  • Selected Requirements of Prescribing Information (SRPI)
  • FDA Patient Labeling Resources
  • Medication Guides
  • Instructions for Use
  • National Drug Codes
  • Industry-standard labeling trends
  • DUNS and FEI Registrations
• Excellent communication, collaboration, and interpersonal skills to work effectively with cross-functional teams and key stakeholders.
• Strong problem-solving abilities with keen attention to detail and adherence to federal requirements and best practices.
• Proven ability to independently manage labeling processes, prioritize tasks, and drive successful outcomes.

Skillsets:

• Regulatory Labeling
• PLR
• SRPI
• Container Labeling

Education:

• Associate’s degree

About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more, please visit: www.ustechsolutions.com
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.